Home / Recalls / Prescript Pharmaceuticals, Inc. / D-0809-2018

D-0809-2018 Class II Terminated

Recalled by Prescript Pharmaceuticals, Inc. — Pleasanton, CA

Recall Details

Product Type
Drugs
Report Date
May 23, 2018
Initiation Date
April 24, 2018
Termination Date
January 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
199 tablets in 20-count containers

Product Description

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

Reason for Recall

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).

Distribution Pattern

California.

Code Information

Lot # 0130130 EXP 12/31/20

Other recalls by Prescript Pharmaceuticals, Inc.

  • D-0808-2018 Class II — Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: (April 24, 2018)
  • D-0807-2018 Class II — Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratori (April 24, 2018)
  • D-0805-2018 Class II — Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett C (April 24, 2018)
  • D-0806-2018 Class II — Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak c (April 24, 2018)