Prescript Pharmaceuticals Recalls Clindamycin Capsules Due to Labeling Error
Prescript Pharmaceuticals is recalling Clindamycin 300 mg capsules because the storage temperature label differs from the manufacturer's original declaration.
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 minor labeling error regarding storage temperature, which fits the criteria for a moderate severity recall.
Plain-English summary
Prescript Pharmaceuticals, Inc. is recalling 5 containers of Clindamycin 300 mg capsules, USP, 28-count M-Pak containers. The product was manufactured for Lannett Co. Inc. and packaged by PreScript Pharm. Inc. The recall is limited to Lot # 0130132 with an expiration date of 3/31/19. The affected units were distributed in California.
The recall was initiated due to a labeling error. The product label declares a storage temperature of 15°C to 30°C (59°F to 86°F), which differs from the original manufacturer's declaration of 20°C to 25°C (68°F to 77°F). This discrepancy is classified as a labeling issue not elsewhere classified.
Consumers and healthcare providers with this specific lot of Clindamycin capsules should stop using the product and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11
- Manufacturer
- Prescript Pharmaceuticals, Inc.
- Category
- Drug — Antibiotic
- Hazard
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 # 0130132
- EXP 3/31/19
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Prescript Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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