Teva Recalls Penicillin V Potassium Due to Impurity Test Failures
Teva Pharmaceuticals is recalling specific bottles of Penicillin V Potassium oral solution because they failed impurity and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is recalling 42,384 bottles of Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL. The recall affects Lot # 35433115A with an expiration date of 01/18. The product is a prescription-only medication manufactured in Canada by Teva Canada Limited and distributed nationwide in the USA and Puerto Rico.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, high out-of-specification test results were obtained for individual and total impurities. This is an FDA Class III recall, which indicates that the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM)
- Brand
- PENICILLIN V POTASSIUM
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 42,384
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 # 35433115A
- Exp 01/18
UPCs (3)
- 0300934125733
- 0300931172013
- 0300934127737
Distribution
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