Physicians Total Care Recalls Belladonna Alkaloids Tablets Due to Foreign Substance
Physicians Total Care is recalling Belladonna Alkaloids/PB tablets due to the presence of black spots on the tablets.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a foreign substance (black spots) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Physicians Total Care, Inc. is recalling Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets, 30-count bottles (NDC 54868-0031-04). The product is repackaged and distributed by Physicians Total Care, Inc. in Tulsa, OK.
The recall was initiated in response to a recall by the manufacturer, West-Ward Pharmaceutical, regarding the presence of black spots on the tablets. The specific lot number is 6GP2 with an expiration date of 10/14, and the West-Ward lot number is WWCN 67331A.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Tablets
- Hazard
- Affected units
- 270
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 6GP2
- Exp 10/14 West-Ward Lot /WWCN 67331A
Distribution
Distributed in 1 state:
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