Drug 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

D-0808-2018

April 24, 2018

Class II

Product summary

Firm: Prescript Pharmaceuticals, Inc.
Event: Event 79961
Status: Terminated
Classification: Class II
Quantity: 5 28-count containers
Official record key: drug-enforcement:D-0808-2018

Official wording

Reason: Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

Code information: Lot # 0130132, EXP 3/31/19

Distribution pattern: California.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).