Home / Recalls / Preferred Pharmaceuticals, Inc. / D-0505-2024

D-0505-2024 Class II Ongoing

Recalled by Preferred Pharmaceuticals, Inc. — Anaheim, CA

Recall Details

Product Type
Drugs
Report Date
May 29, 2024
Initiation Date
May 10, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
66 bottles of 30 tablets

Product Description

Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Reason for Recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Distribution Pattern

Product distributed to CA, FL, OK, KS and CT

Code Information

Lot #: J2022G, Exp: 01/01/2025

Other recalls by Preferred Pharmaceuticals, Inc.

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  • D-0391-2025 Class II — Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured b (April 18, 2025)
  • D-0647-2024 Class II — Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottl (August 8, 2024)
  • D-0894-2023 Class II — Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788- (June 26, 2023)
  • D-0504-2023 Class II — Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceu (March 27, 2023)
  • D-0506-2023 Class II — Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596- (March 27, 2023)
  • D-0505-2023 Class II — Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-759 (March 27, 2023)
  • D-0511-2023 Class II — Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured (March 23, 2023)
  • D-0514-2023 Class II — Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord He (March 23, 2023)
  • D-0515-2023 Class II — Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord He (March 23, 2023)