Torrent Pharma Recalls Hydrocortisone Acetate Suppositories Due to Contamination Risk
Torrent Pharma Inc. is recalling Hydrocortisone Acetate Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves potential contamination with Burkholderia cepacia and Ralstonia pickettii, which are high-risk pathogens associated with serious infections, meeting the criteria for a Severe rating.
Plain-English summary
Torrent Pharma Inc. is recalling Hydrocortisone Acetate Suppositories, 25 mg, for rectal administration. The recall involves 140,436 suppositories in cartons of 12 and 24, manufactured by Bio-Pharm Inc. The affected lots include 17L010, 18D018, 18F022, 18F022A, 17L019, 17L026, 18B005, 18D006, 18D012, 18D022, and 18K006.
The recall is being conducted due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The FDA has classified this as a Class II recall.
The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States. Consumers and healthcare providers should stop using the recalled suppositories and contact their healthcare provider or pharmacist for guidance on alternative treatments.
The recalled product
- Product
- Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Suppositories
- Affected units
- 140,436
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 (15)
- Lot #s: a) 17L010
- Exp. 11/2019
- 18D018
- Exp. 04/2020
- 18F022
- 18F022A
- Exp. 06/2020. b) 17L019
- 17L026
- 18B005
- Exp. 02/2020
- 18D006
- 18D012
- 18D022
- 18K006
- Exp. 10/2020.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 41 recalled by Torrent Pharma Inc 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.
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