Physicians Total Care Recalls Arthrotec 75 Tablets Due to Broken Tablets
Physicians Total Care is recalling specific lots of Arthrotec 75 tablets because they may contain broken tablets. The recall affects products distributed in North Carolina and Kentucky.
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. The hazard involves broken tablets, which is a quality defect that may affect drug integrity but does not present an immediate, life-threatening risk like a high-risk pathogen or structural vehicle defect, fitting the Moderate category for minor labeling or quality errors.
Plain-English summary
Physicians Total Care, Inc. is voluntarily recalling specific lots of Arthrotec 75 (diclofenac sodium and misoprostol) tablets. The product is a prescription medication manufactured by G.D. Searle LLC Div Pfizer and repacked and distributed by Physicians Total Care, Inc. The recall involves 30-count and 60-count bottles of the medication.
The recall is being conducted because the manufacturer of Arthrotec recalled the original lots used to re-package this product. The source text states that these lots may contain broken tablets. The affected lots are identified by specific lot numbers and expiration dates, including 5NON (Exp 04/13), 5YUN (Exp 09/13), 5KBJ (Exp 02/13), and 5LVX (Exp 04/13).
The affected products were distributed in North Carolina and Kentucky. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, as per standard recall procedures.
The recalled product
- Product
- Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians…
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Prescription Medication
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 (7)
- Lot #: a) 5NON
- Exp 04/13
- 5YUN
- Exp 09/13
- b) 5KBJ
- Exp 02/13
- 5LVX
Distribution
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