Why it was recalled
Lack of assurance of sterility
Product description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.
Lot numbers, UPCs & expiration codes
Lots#: JKX4312A & JKX4313A, Exp 09/2022; JKX4827A, Exp 09/2023; HAC1290A & HAC2082B, Exp 06/2023;
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1143-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 6, 2022
- FDA report date
- Jun 22, 2022
- Quantity
- 79339 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-1143-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90151
- Address
- 2 Independence Way
- Code information
- Lots#: JKX4312A & JKX4313A, Exp 09/2022; JKX4827A, Exp 09/2023; HAC1290A & HAC2082B, Exp 06/2023;
- Postal code
- 08540-6620
- Report date
- Jun 22, 2022
- Product type
- Drugs
- Recall number
- D-1143-2022
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 79339 syringes
- Termination date
- Aug 14, 2023
- Reason for recall
- Lack of assurance of sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 6, 2022
- Center classification date
- Jun 10, 2022