Reported Dec 26, 2018 · Terminated
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar…
Sun Pharmaceutical Industries, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only
- Manufactured byGalephar Pharmaceutical Research Inc. Humacao, PR 00792
- Distributed bySun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)
- Lot codes and dates
- Lot
17F28AAExp 1/2020
- Lot
- Amount recalled
- 47,520 prescription packs
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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