The Recall Desk
ModerateFDA (Drugs)·D-0805-2018·Announced 2018-05-23

Prescript Pharmaceuticals Recalls Clindamycin Capsules Due to Labeling Error

Prescript Pharmaceuticals is recalling 50 containers of Clindamycin 150 mg capsules in California due to a storage temperature labeling discrepancy.

What this means for you

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 score.

Plain-English summary

Prescript Pharmaceuticals, Inc. is recalling 50 30-count containers of Clindamycin 150 mg capsules, USP. The product was manufactured by Lannett Co. Inc. and packaged by PreScript Pharm. Inc. The specific lot number is 0130126, with NDC 00527-1382-01 and Bar Code 0639-30-176.

The recall was initiated due to a labeling error regarding storage instructions. The recalled containers are labeled to be stored at 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.

The affected product was distributed in California. Consumers who have this specific lot of Clindamycin capsules should contact their healthcare provider or pharmacist for guidance on whether to continue using the medication or obtain a replacement.

The recalled product

Product
Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176

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 (1)

  • Lot # 0130126

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.

See all 5 products in this recall →