Percocet 10/325 mg Tablets Recalled Due to Foreign Tablet Presence
Physicians Total Care is recalling one bottle of Percocet 10/325 mg tablets because it contained a foreign Endocet 10/25 mg tablet.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the Low severity criterion for minor or theoretical risks.
Plain-English summary
Physicians Total Care, Inc. is recalling one bottle of Percocet 10/325 mg tablets, 100-count, Rx only. The product is distributed by Physicians Total Care in Tulsa, OK, and manufactured by Novartis Consumer Health I in Lincoln, NE. The specific lot number is 6IHD with an expiration date of 09/30/2013.
The recall was initiated because a tablet of Endocet 10/25 mg, a generic form, was found inside the bottle of Percocet 10/325 mg tablets. This constitutes a presence of foreign tablets/capsules. The distribution pattern is listed as FL.
Consumers who possess this specific product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD.
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 1
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 # 6IHD
- Exp 09/30/2013
Distribution
Distributed in 1 state:
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