Food, drugs, devices › Unipharma, Llc.
Drug recall: CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mi
FDA enforcement event 83492 is a drug recall by Unipharma, Llc. of Tamarac, FL, initiated 15 Jul 2019 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 5 Jun 2020. Initiation: voluntary: firm initiated. Unipharma, Llc. has 3 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Unipharma, Llc., Tamarac, FL.
Reason for recall
"CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia."
Distribution
"Nationwide in the US."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1631-2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC… | 48 cartons | Class II | Terminated | 14 Aug 2019 |
| D-1632-2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010 | 432 cartons | Class II | Terminated | 14 Aug 2019 |
| D-1633-2019 | CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207 | 48 cartons | Class II | Terminated | 14 Aug 2019 |
Context
Other enforcement events for Unipharma, Llc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Sep 2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Ea | Drug | Class II | 2 |
| 2 May 2019 | CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor | Drug | Class II | 11 |
All 3 events for Unipharma, Llc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the US."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.