Food, drugs, devices › Physicians Total Care, Inc.

Drug recall: Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.

FDA enforcement event 65601 · Class II · initiated 17 Jun 2013 · status Terminated · terminated 15 Aug 2013

DrugVoluntary: Firm initiated1 product recordTulsa, OK

FDA enforcement event 65601 is a drug recall by Physicians Total Care, Inc. of Tulsa, OK, initiated 17 Jun 2013 and classified Class II, with 1 product record.

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. 56% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 15 Aug 2013. Initiation: voluntary: firm initiated. Physicians Total Care, Inc. has 17 enforcement events on this register, with a median of 1 product record 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

Physicians Total Care, Inc., Tulsa, OK.

Reason for recall

"Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall."

Distribution

"GA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-826-2013	Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146.	270 tablets	Class II	Terminated	7 Aug 2013

Context

56%of 2013 drug events are Class II370 events that year

1product record in this eventfirm median: 1

17events on this register for the firm

Other enforcement events for Physicians Total Care, Inc.

Initiated	Product (first record)	Type	Class	Records
22 Sep 2014	CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit,	Drug	Class II	1
22 Nov 2013	Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repa	Drug	Class II	1
11 Sep 2013	Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed	Drug	Class III	1
18 Mar 2013	Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEV	Drug	Class III	1
2 Mar 2013	Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health,	Drug	Class III	1
15 Nov 2012	Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians	Drug	Class II	1
20 Feb 2012	PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 1896	Drug	Class II	2
8 Feb 2012	Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa O	Drug	Class II	1
19 Sep 2011	Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-	Drug	Class II	1
23 May 2011	Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg	Drug	Class III	1

All 17 events for Physicians Total Care, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall."

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: "GA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Aug 2013. "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.