Drug recall: atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only…
Class I FDA enforcement event 73925. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Pharmedium Services, LLC started this drug recall on 17 Jul 2015. The firm address in the FDA record is in Lake Forest, IL. FDA put the recall in Class I. FDA event 73925 has 69 product records. The first FDA enforcement report date is 19 Oct 2016. The record gives the status Terminated, with the termination date 23 Jun 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Pharmedium Services, LLC, Lake Forest, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
69 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0025-2017 | atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324. | 4407 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0026-2017 | atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335. | 5568 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0027-2017 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466. | 660 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0028-2017 | Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475. | 10 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0029-2017 | ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301. | 995 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0030-2017 | ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308. | 1478 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0031-2017 | ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347. | 1545 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0032-2017 | Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228. | 210 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0033-2017 | fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40 | 50 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0034-2017 | fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153. | 4347 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0035-2017 | fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174. | 8955 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0036-2017 | fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236. | 110 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0037-2017 | fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303. | 53357 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0038-2017 | fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306. | 997 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0039-2017 | fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318. | 1522 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0040-2017 | fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339. | 1561 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0041-2017 | fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424. | 616 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0042-2017 | fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479. | 1735 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0043-2017 | fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107. | 10 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0044-2017 | glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217. | 16366 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0045-2017 | glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329. | 17462 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0046-2017 | glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340. | 1494 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0047-2017 | HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210. | 399 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0048-2017 | HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925. | 240 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0049-2017 | HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926. | 350 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0050-2017 | HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162. | 1916 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0051-2017 | HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352. | 4860 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0052-2017 | HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165 | 450 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0053-2017 | ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234. | 25 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0054-2017 | ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320. | 1500 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0055-2017 | ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330. | 9101 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0056-2017 | ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348. | 12,173 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0057-2017 | ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500. | 54 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0058-2017 | labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117. | 969 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0059-2017 | lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140. | 3285 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0060-2017 | lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102. | 2961 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0061-2017 | lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104. | 500 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0062-2017 | lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106. | 499 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0063-2017 | lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345. | 5900 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0064-2017 | lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391. | 300 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0065-2017 | lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112. | 6324 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0066-2017 | lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79 | 830 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0067-2017 | lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384. | 512 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0068-2017 | lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80 | 1161 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0069-2017 | lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450. | 3159 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0070-2017 | methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120. | 7006 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0071-2017 | methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6134. | 200 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0072-2017 | methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149. | 7556 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0073-2017 | midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196. | 1700 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0074-2017 | midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351. | 4058 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0075-2017 | midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356. | 26079 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0076-2017 | morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017. | 3270 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0077-2017 | morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119. | 935 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0078-2017 | morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181. | 592 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0079-2017 | morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259. | 21506 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0080-2017 | morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353. | 545 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0081-2017 | morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455. | 25 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0082-2017 | neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326. | 21053 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0083-2017 | neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550. | 250 syringes | Class II | Terminated | 19 Oct 2016 |
| D-0084-2017 | neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551. | 700 syringes | Class II | Terminated | 19 Oct 2016 |
The table shows 60 of 69 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2015
- 292
- Share of these events in Class I
- 17%
- Product records in this event
- 69Median of the firm: 2
- Events of the firm on the register
- 30
Other events of the firm
Official channels
- FDA enforcement report D-0025-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 73925. https://recallregister.com/fda/i/73925/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 73925?
- The event has 69 product records. The first record gives this quantity:
4407 syringes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2015 have the same class?
- 17% of the 292 drug events that started in 2015 are in Class I.