Appco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
Appco Pharma LLC is recalling specific lots of Ranitidine Capsules 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
Appco Pharma LLC is recalling specific bottles of Ranitidine Capsules 150 mg, prescription only, manufactured by Appco Pharma LLC and distributed by ANI Pharmaceuticals, Inc. The recall involves 624 bottles in 60-count and 500-count sizes. The affected batches are identified by specific lot numbers and expiration dates ranging from April 2021 to May 2021.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the discovery of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). The product was distributed to six major distributors and wholesalers, some with multiple locations, who may have further distributed the product.
Consumers and healthcare providers should stop using the affected Ranitidine Capsules 150 mg and return them to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
- Manufacturer
- Appco Pharma LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 624
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Batch # 1905225VN
- exp. date Apr-2021 1905226VD
- exp. date Apr-2021 1906295UN
- exp. date May-2021 1906296UN
- exp. date May-2021 1906297UN
- exp. date May-2021 1906298UD
- exp. date May-2021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Appco Pharma LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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