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Recall Observatory FDA recall evidence

Drug product

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834

D-0809-2018

April 24, 2018

Class II

Product summary

Firm
Prescript Pharmaceuticals, Inc.
Event
Event 79961
Status
Terminated
Classification
Class II
Quantity
199 tablets in 20-count containers
Official record key
drug-enforcement:D-0809-2018

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 # 0130130 EXP 12/31/20

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).