FDAFDA · Food and drugs·Recall number D-1246-2020
Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433
Published April 22, 2020 · Recall initiated: April 15, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- H J Harkins Company Inc dba Pharma Pac
- Distributor
- Product was distributed in CA and AZ.
- Lot
- Lot # ATP12ZT, Exp. 05/21
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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